StrokeNCT05985603
Comparison of Mirror Therapy and Modified Constrain Induced Movement Therapy on Risk of Fall, Balance and Gait in Stroke
A study testing CIMT Group and Mirror Therapy group in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
There will be a difference between modified constraint induced movement therapy and Mirror Therapy on lower limb for risk of fall, balance and gait in stroke patients. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- CIMT Group and Mirror Therapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2023to 15 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A Hemiplegia due to unilateral stroke
- Sub-acute and chronic stroke
- Stroke survivors between 21 and 70 years old will be recruited
- Both genders
- NIH Stroke scale below 20
- Mini-Mental State Examination above 24
- Function in Sitting Test (FIST) above 42/56
Who cannot join
- Patients with depression who will be unable to cooperate during treatment
- Patients who cannot perform the active movement of limb due to prestroke muscoskeletal problems
- Cardiopulmonary diseases which could hinder their ability to participate in rehabilitation
- Spasticity of Modified Ashworth Scale (MAS) II or higher
- Patients with Any neuron disease and Patients with lower-limb impairment caused by other neurological diseases or inability to comply with study protocol will be excluded.
- Visual and auditory abnormalities
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Helping Hand Institute Of rehabilitation sciences
Mansehra, KPK, 21300
About this study
There will be a difference between modified constraint induced movement therapy and Mirror Therapy on lower limb for risk of fall, balance and gait in stroke patients.
- Conditions
- Stroke
- Being tested
- CIMT Group, Mirror Therapy group
- Keywords
- CIMT, Mirror Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIMT GroupOther
In this group of patients CIMT technique will be used for treatment
Mirror Therapy groupOther
patient will perform movements in semi-reclined and sitting positions with the mirror placed between the two lower extremities.
| Study group | Role | What they receive |
|---|---|---|
| CIMT Group | Experimental | In this group of patients CIMT technique will be used for treatment Receives: Other: CIMT Group |
| Mirror Therapy Group | Experimental | patient will perform movements in semi-reclined and sitting positions with the mirror placed between the two lower extremities. Receives: Other: Mirror Therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIH Stroke Scale - NIHSS
It comprises of 15 items with each having responses scored on a 0-4 points scale. The overall score ranges from 0-42 points with higher scores specifying pronounced neurological deficits
Measured: 2,4,8 week
Mini-mental state examination
Cognitive status by the mini-mental state examination (mmse)Mini-Mental State Examination (MMSE) is a tool that can quickly diagnose if a person suffers from mild cognitive impairment (MCI) through answering questions in different cognitive domains. The MMSE demonstrates moderately high levels of reliability. It has been reported to be internally consistent
Measured: 2,4,8 week
POMA
After interventions POMA for assessing risk of fall will be used. The POMA is used to examine balance and mobility in the elderly (Tinetti 1986). This examination tool consists of the balance subscale (9 items, 16 points) and gait subscale (8 items, 12 points), totaling 28 points.
Measured: 2,4,8 week
Berg balance scale
A five-point scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Total Score = 0-56. Score of 41-56 = low fall risk, 21-40 = medium fall risk, 0-20 = high fall risk.
Measured: 2,4,8 week
10 Meter walk test / 10mwt
Calculating Gait Speed - total distance/time. For example: if you did a 10-meter gait speed test and it took you 7 seconds, the equation would like: 10 meters / 7 seconds = 1.4 meters per second. The 10MWT intra-rater and inter-rater reliability were good (ICC between 0.76 until 0.9) and excellent (ICC > 0.9), respectively. The minimal detectable change for intra-rater reliability was 0.188 m/s.
Measured: 2,4,8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Apr 2023
- Primary completion30 Jan 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayesha Bashir, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985603
- Sponsor's protocol ID
- REC/01665 Bakhtawar Tariq
- Status last verified
- Nov 2025
- First submitted
- 3 Aug 2023
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oh K, Im N, Lee Y, Lim N, Cho T, Ryu S, Yoon S. Effect of Antigravity Treadmill Gait Training on Gait Function and Fall Risk in Stroke Patients. Ann Rehabil Med. 2022 Jun;46(3):114-121. doi: 10.5535/arm.22034. Epub 2022 Jun 30.
PubMed 35793900Okonkwo UP, Agbo CF, Ibeneme SC, Igwe ES, Akosile CO, Onwuakagba IU, Emmanuel OC, Maduagwu SM, Ezenwankwo EF, Ekechukwu EN. The Burden and Quality of life of Caregivers of Stroke Survivors with Cognitive Impairment in Selected Healthcare Facilities in Anambra State, Nigeria. Gerontol Geriatr Med. 2022 Sep 27;8:23337214221126329. doi: 10.1177/23337214221126329. eCollection 2022 Jan-Dec.
PubMed 36189374Wagatsuma M, Kim T, Sitagata P, Lee E, Vrongistinos K, Jung T. The biomechanical investigation of the relationship between balance and muscular strength in people with chronic stroke: a pilot cross-sectional study. Top Stroke Rehabil. 2019 Apr;26(3):173-179. doi: 10.1080/10749357.2019.1574417. Epub 2019 Feb 11.
PubMed 30741610Khan F, Abusharha S, Alfuraidy A, Nimatallah K, Almalki R, Basaffar R, Mirdad M, Chevidikunnan MF, Basuodan R. Prediction of Factors Affecting Mobility in Patients with Stroke and Finding the Mediation Effect of Balance on Mobility: A Cross-Sectional Study. Int J Environ Res Public Health. 2022 Dec 10;19(24):16612. doi: 10.3390/ijerph192416612.
PubMed 36554493Li J, Zhong D, Ye J, He M, Liu X, Zheng H, Jin R, Zhang SL. Rehabilitation for balance impairment in patients after stroke: a protocol of a systematic review and network meta-analysis. BMJ Open. 2019 Jul 19;9(7):e026844. doi: 10.1136/bmjopen-2018-026844.
PubMed 31326927Arienti C, Lazzarini SG, Pollock A, Negrini S. Rehabilitation interventions for improving balance following stroke: An overview of systematic reviews. PLoS One. 2019 Jul 19;14(7):e0219781. doi: 10.1371/journal.pone.0219781. eCollection 2019.
PubMed 31323068Herrador Colmenero L, Perez Marmol JM, Marti-Garcia C, Querol Zaldivar MLA, Tapia Haro RM, Castro Sanchez AM, Aguilar-Ferrandiz ME. Effectiveness of mirror therapy, motor imagery, and virtual feedback on phantom limb pain following amputation: A systematic review. Prosthet Orthot Int. 2018 Jun;42(3):288-298. doi: 10.1177/0309364617740230. Epub 2017 Nov 20.
PubMed 29153043Ju Y, Yoon IJ. The effects of modified constraint-induced movement therapy and mirror therapy on upper extremity function and its influence on activities of daily living. J Phys Ther Sci. 2018 Jan;30(1):77-81. doi: 10.1589/jpts.30.77. Epub 2018 Jan 27.
PubMed 29410571Garrido M M, Alvarez E E, Acevedo P F, Moyano V A, Castillo N N, Cavada Ch G. Early transcranial direct current stimulation with modified constraint-induced movement therapy for motor and functional upper limb recovery in hospitalized patients with stroke: A randomized, multicentre, double-blind, clinical trial. Brain Stimul. 2023 Jan-Feb;16(1):40-47. doi: 10.1016/j.brs.2022.12.008. Epub 2022 Dec 28.
PubMed 36584748E Silva EMGS, Ribeiro TS, da Silva TCC, Costa MFP, Cavalcanti FADC, Lindquist ARR. Effects of constraint-induced movement therapy for lower limbs on measurements of functional mobility and postural balance in subjects with stroke: a randomized controlled trial. Top Stroke Rehabil. 2017 Dec;24(8):555-561. doi: 10.1080/10749357.2017.1366011. Epub 2017 Aug 31.
PubMed 28859603Wang D, Xiang J, He Y, Yuan M, Dong L, Ye Z, Mao W. The Mechanism and Clinical Application of Constraint-Induced Movement Therapy in Stroke Rehabilitation. Front Behav Neurosci. 2022 Jun 21;16:828599. doi: 10.3389/fnbeh.2022.828599. eCollection 2022.
PubMed 35801093Yoon JA, Koo BI, Shin MJ, Shin YB, Ko HY, Shin YI. Effect of constraint-induced movement therapy and mirror therapy for patients with subacute stroke. Ann Rehabil Med. 2014 Aug;38(4):458-66. doi: 10.5535/arm.2014.38.4.458. Epub 2014 Aug 28.
PubMed 25229024Kim K, Lee S, Kim D, Lee K, Kim Y. Effects of mirror therapy combined with motor tasks on upper extremity function and activities daily living of stroke patients. J Phys Ther Sci. 2016 Jan;28(2):483-7. doi: 10.1589/jpts.28.483. Epub 2016 Feb 29.
PubMed 27065534
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mirror Therapy and Modified Constrain Induced Movement Therapy on Risk of Fall, Balance and Gait in Stroke
- ClinicalTrials.gov ID
- NCT05985603
- Acronym / sponsor ID
- REC/01665 Bakhtawar Tariq
- Conditions
- Stroke
- Keywords
- CIMT, Mirror Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There will be a difference between modified constraint induced movement therapy and Mirror Therapy on lower limb for risk of fall, balance and gait in stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIMT Group | Experimental | Other: CIMT GroupIn this group of patients CIMT technique will be used for treatment |
| Mirror Therapy Group | Experimental | Other: Mirror Therapy grouppatient will perform movements in semi-reclined and sitting positions with the mirror placed between the two lower extremities. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A Hemiplegia due to unilateral stroke
- Sub-acute and chronic stroke
- Stroke survivors between 21 and 70 years old will be recruited
- Both genders
- NIH Stroke scale below 20
Key exclusion criteria (6 listed)
- Patients with depression who will be unable to cooperate during treatment
- Patients who cannot perform the active movement of limb due to prestroke muscoskeletal problems
- Cardiopulmonary diseases which could hinder their ability to participate in rehabilitation
- Spasticity of Modified Ashworth Scale (MAS) II or higher
- Patients with Any neuron disease and Patients with lower-limb impairment caused by other neurological diseases or inability to comply with study protocol will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CIMT GroupIn this group of patients CIMT technique will be used for treatment | Other | CIMT Group |
| Mirror Therapy grouppatient will perform movements in semi-reclined and sitting positions with the mirror placed between the two lower extremities. | Other | Mirror Therapy Group |
Primary outcome
NIH Stroke Scale - NIHSS
Time frame: 2,4,8 week
It comprises of 15 items with each having responses scored on a 0-4 points scale. The overall score ranges from 0-42 points with higher scores specifying pronounced neurological deficits
Mini-mental state examination
Time frame: 2,4,8 week
Cognitive status by the mini-mental state examination (mmse)Mini-Mental State Examination (MMSE) is a tool that can quickly diagnose if a person suffers from mild cognitive impairment (MCI) through answering questions in different cognitive domains. The MMSE demonstrates moderately high levels of reliability. It has been reported to be internally consistent
POMA
Time frame: 2,4,8 week
After interventions POMA for assessing risk of fall will be used. The POMA is used to examine balance and mobility in the elderly (Tinetti 1986). This examination tool consists of the balance subscale (9 items, 16 points) and gait subscale (8 items, 12 points), totaling 28 points.
Berg balance scale
Time frame: 2,4,8 week
A five-point scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Total Score = 0-56. Score of 41-56 = low fall risk, 21-40 = medium fall risk, 0-20 = high fall risk.
10 Meter walk test / 10mwt
Time frame: 2,4,8 week
Calculating Gait Speed - total distance/time. For example: if you did a 10-meter gait speed test and it took you 7 seconds, the equation would like: 10 meters / 7 seconds = 1.4 meters per second. The 10MWT intra-rater and inter-rater reliability were good (ICC between 0.76 until 0.9) and excellent (ICC > 0.9), respectively. The minimal detectable change for intra-rater reliability was 0.188 m/s.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Background: PubMed 35793900Oh K, Im N, Lee Y, Lim N, Cho T, Ryu S, Yoon S. Effect of Antigravity Treadmill Gait Training on Gait Function and Fall Risk in Stroke Patients. Ann Rehabil Med. 2022 Jun;46(3):114-121. doi: 10.5535/arm.22034. Epub 2022 Jun 30.
- Background: PubMed 36189374Okonkwo UP, Agbo CF, Ibeneme SC, Igwe ES, Akosile CO, Onwuakagba IU, Emmanuel OC, Maduagwu SM, Ezenwankwo EF, Ekechukwu EN. The Burden and Quality of life of Caregivers of Stroke Survivors with Cognitive Impairment in Selected Healthcare Facilities in Anambra State, Nigeria. Gerontol Geriatr Med. 2022 Sep 27;8:23337214221126329. doi: 10.1177/23337214221126329. eCollection 2022 Jan-Dec.
- Background: PubMed 30741610Wagatsuma M, Kim T, Sitagata P, Lee E, Vrongistinos K, Jung T. The biomechanical investigation of the relationship between balance and muscular strength in people with chronic stroke: a pilot cross-sectional study. Top Stroke Rehabil. 2019 Apr;26(3):173-179. doi: 10.1080/10749357.2019.1574417. Epub 2019 Feb 11.
- Background: PubMed 36554493Khan F, Abusharha S, Alfuraidy A, Nimatallah K, Almalki R, Basaffar R, Mirdad M, Chevidikunnan MF, Basuodan R. Prediction of Factors Affecting Mobility in Patients with Stroke and Finding the Mediation Effect of Balance on Mobility: A Cross-Sectional Study. Int J Environ Res Public Health. 2022 Dec 10;19(24):16612. doi: 10.3390/ijerph192416612.
- Background: PubMed 31326927Li J, Zhong D, Ye J, He M, Liu X, Zheng H, Jin R, Zhang SL. Rehabilitation for balance impairment in patients after stroke: a protocol of a systematic review and network meta-analysis. BMJ Open. 2019 Jul 19;9(7):e026844. doi: 10.1136/bmjopen-2018-026844.
- Background: PubMed 31323068Arienti C, Lazzarini SG, Pollock A, Negrini S. Rehabilitation interventions for improving balance following stroke: An overview of systematic reviews. PLoS One. 2019 Jul 19;14(7):e0219781. doi: 10.1371/journal.pone.0219781. eCollection 2019.
- Background: PubMed 29153043Herrador Colmenero L, Perez Marmol JM, Marti-Garcia C, Querol Zaldivar MLA, Tapia Haro RM, Castro Sanchez AM, Aguilar-Ferrandiz ME. Effectiveness of mirror therapy, motor imagery, and virtual feedback on phantom limb pain following amputation: A systematic review. Prosthet Orthot Int. 2018 Jun;42(3):288-298. doi: 10.1177/0309364617740230. Epub 2017 Nov 20.
- Background: PubMed 29410571Ju Y, Yoon IJ. The effects of modified constraint-induced movement therapy and mirror therapy on upper extremity function and its influence on activities of daily living. J Phys Ther Sci. 2018 Jan;30(1):77-81. doi: 10.1589/jpts.30.77. Epub 2018 Jan 27.
- Background: PubMed 36584748Garrido M M, Alvarez E E, Acevedo P F, Moyano V A, Castillo N N, Cavada Ch G. Early transcranial direct current stimulation with modified constraint-induced movement therapy for motor and functional upper limb recovery in hospitalized patients with stroke: A randomized, multicentre, double-blind, clinical trial. Brain Stimul. 2023 Jan-Feb;16(1):40-47. doi: 10.1016/j.brs.2022.12.008. Epub 2022 Dec 28.
- Background: PubMed 28859603E Silva EMGS, Ribeiro TS, da Silva TCC, Costa MFP, Cavalcanti FADC, Lindquist ARR. Effects of constraint-induced movement therapy for lower limbs on measurements of functional mobility and postural balance in subjects with stroke: a randomized controlled trial. Top Stroke Rehabil. 2017 Dec;24(8):555-561. doi: 10.1080/10749357.2017.1366011. Epub 2017 Aug 31.
- Background: PubMed 35801093Wang D, Xiang J, He Y, Yuan M, Dong L, Ye Z, Mao W. The Mechanism and Clinical Application of Constraint-Induced Movement Therapy in Stroke Rehabilitation. Front Behav Neurosci. 2022 Jun 21;16:828599. doi: 10.3389/fnbeh.2022.828599. eCollection 2022.
- Background: PubMed 25229024Yoon JA, Koo BI, Shin MJ, Shin YB, Ko HY, Shin YI. Effect of constraint-induced movement therapy and mirror therapy for patients with subacute stroke. Ann Rehabil Med. 2014 Aug;38(4):458-66. doi: 10.5535/arm.2014.38.4.458. Epub 2014 Aug 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayesha Bashir, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CIMT Group and Mirror Therapy group in people with Stroke, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIH Stroke Scale - NIHSS (time frame: 2,4,8 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05985603, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.